This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker. Participants with colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer will be included.

Inclusion Criteria:

• Participants must be at least 18 years of age.
• Participants must have metastatic colorectal cancer (CRC), recurrent or metastatic head & neck (H&N) or esophageal cancer, or locally advanced, inoperable, or metastatic non-small cell lung cancer (NSCLC).
• Participants must have a tumor sample or a blood sample tested positive for the presence of the biomarker.
• Participants may have up to 3 prior regimens for CRC, up to 3 prior regimens for NSCLC, up to 2 prior regimens for H&N and esophageal cancer.
• Participants must have at least one measurable lesion.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Participants must have adequate hematologic, renal, and liver functions.
• Participants must be able to take the study medication capsules orally, or through a feeding tube without the capsules being opened.
• Participants of childbearing potential must agree to use a medically accepted method of contraception.

Exclusion Criteria:

• Participants who have received treatment for a second malignancy within 1 year before screening, and are considered to be at risk of relapse within 1 year after screening.
• Participants with unstable or progressing central nervous system (CNS) metastasis. Participants with known CNS metastasis may be included if a) the subject is asymptomatic, b) there is no requirement for steroids or antiseizure medications, or the required doses are stable, and c) there is no associated midline shift or (in the opinion of the investigator) significant edema.
• Participants who received prior temozolomide or dacarbazine treatment

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf

http://engagezone.msd.com/ds\_documentation.php

Other adverse events: these non-serious events are treatment-emergent.

Due to low response rate for colorectal cancer in interim analyses, low enrollment in head & neck and non-small cell lung cancer groups due to low methylation rates, and low overall response rate in esophageal cancer group, the study was terminated.